Cartesian's Descartes-08 Granted Rare Pediatric Disease Designation By FDA To Treat JDM

(RTTNews) - Cartesian Therapeutics, Inc. (RNAC), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, announced Monday that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis or JDM.

The company noted that IND filing for Phase 2 pediatric basket study is on track for year-end.

Descartes-08, Cartesian's lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy or mRNA CAR-T product candidate targeting B-cell maturation antigen (BCMA).

It is designed to be administered without preconditioning chemotherapy and does not use integrating vectors.

JDM is a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems including the joints, heart, lungs, kidneys, eyes, and gastrointestinal systems.

The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States.

Under the FDA's Rare Pediatric Disease Designation and Voucher Program, if Decartes-08 is approved for marketing in JDM, Cartesian may qualify for a priority review voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product.

Carsten Brunn, President and Chief Executive Officer of Cartesian, said, "Leveraging our novel mRNA platform, we are committed to our mission of expanding the reach of cell therapy to patients with autoimmune diseases. We remain on track to file an Investigational New Drug application for a Phase 2 pediatric basket study focused on neurology and rheumatology autoimmune indications, including JDM, by year-end."

For More Such Health News, visit rttnews.com